BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL COLUMBIA CNA AGAR 500 G

    MDR report key: 20863937 · Received December 6, 2024

    Report

    Report Number
    1119779-2024-00963
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 7, 2024
    Report Date
    February 26, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSJ
    UDI-DI
    00382902121046
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR COMPLAINT RELATED TO BOTTLE COLUMBIA CNA AGAR BBL 500G, CATALOG NUMBER: 212104, BATCH NUMBER: 4071443, AND COMPLAINT NUMBER: (B)(4) FOR PERFORMANCE. COMPONENTS ARE MILLED AND BLENDED (WHERE REQUIRED) AND DISPENSED INTO CONTAINERS. FOLLOWING QC RELEASE, AND BASED UPON INVENTORY DEMAND, FINAL PACKAGING OPERATIONS OCCUR, WHICH INCLUDE DISPENSING INTO AND LABELING OF FINAL CONFIGURATIONS, FOLLOWED BY TRANSPORT TO THE DISTRIBUTION CENTER. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD. THE BATCH HISTORY RECORD REVIEW INDICATED NO DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY. RELEASE TESTING CONSISTS OF POWDER APPEARANCE, SOLUBILITY, PREPARED BLOOD PLATE APPEARANCE, PH, AND GROWTH PROMOTION WITH ORGANISMS SPECIFIED ON THE BD CERTIFICATE OF ANALYSIS. THE COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. DURING THAT TIME THERE HAVE BEEN NO COMPLAINTS FOR THIS PRODUCT. NO RETURNS WERE RECEIVED. ONE PHOTO OF THE FRONT OF THE BOTTLE LABELED BBL COLUMBIA CAN AGAR REF: 212104, LOT: 4071443, EXP: 2028-01-31 WAS RECEIVED ALONG WITH THE COMPLAINT. A RETENTION SAMPLE FROM THE COMPLAINT BATCH WAS TESTED FOR GROWTH PROMOTION OF ATCC 27853, PSEUDOMONAS AERUGINOSA, AND ATCC 12453, PROTEUS MIRABILIS, AGAINST A REFERENCE BATCH OF COLUMBIA CNA AGAR. THE SAMPLES WERE PREPARED ACCORDING TO LABEL INSTRUCTIONS. THIS INCLUDES HEATING WITH AGITATION AND BOILING FOR ONE MINUTE. MEDIA WAS AUTOCLAVED AT 121°C FOR 12 MINUTES AND THEN COOLED TO 45-50°C IN A WATER BATH. THE BLOOD PLATES WERE MADE BY USING 5% OF DEFIBRINATED SHEEP BLOOD. THE PLATES OF COLUMBIA CNA AND A TSA II NON-SELECT CONTROL WERE INOCULATED WITH THE TEST ORGANISMS AND INCUBATED AT 33-37°C WITH 3-5 % CO2 FOR 18-24 HOURS. SATISFACTORY PERFORMANCE OF ATCC 27853 IS COMPLETE INHIBITION. NO GROWTH WAS OBSERVED AFTER 18-24 HOURS ON REFERENCE OR RETENTION PLATES. SATISFACTORY PERFORMANCE OF ATCC 12453 IS PARTIAL TO COMPLETE INHIBITION. NO GROWTH WAS OBSERVED AFTER 18-24 HOURS ON REFERENCE OR RETENTION PLATES. THE RETENTION WAS COMPARABLE TO THE REFERENCE. THE NON-SELECT PLATE HAD MODERATE GROWTH OF BOTH ATCC 27853 AND ATCC 12453. IN A PREPARATION DOCUMENT SENT ALONG WITH THE COMPLAINT, IT STATES TO AUTOCLAVE THE MEDIA FOR 15 MINUTES AT 121°C. HOWEVER, PER THE BD LABEL ON THE COLUMBIA CNA AGAR BOTTLE, AUTOCLAVE TIME AND TEMPERATURE ARE 12 MINUTES AND 121°C, RESPECTIVELY. OVERHEATING AND OVER STERILIZATION OF ANY BACTERIOLOGICAL MEDIA MAY CAUSE APPEARANCE AND PERFORMANCE ISSUES. THIS COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE OF BD BBL COLUMBIA CNA AGAR 500 G; AN UNSPECIFIED NUMBER OF PREPARED PLATES HAVE GRAM NEGATIVE ORGANISMS GROWING IN ADDITION TO THE GRAM-POSITIVE ORGANISMS. IN SOME INSTANCES, PROTEUS IS SWARMING WHICH DOES NOT ALLOW FOR GRAM POSITIVE IDENTIFICATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE OF BD BBL COLUMBIA CNA AGAR 500 G, AN UNSPECIFIED NUMBER OF PREPARED PLATES HAVE GRAM NEGATIVE ORGANISMS GROWING IN ADDITION TO THE GRAM POSITIVE ORGANISMS. IN SOME INSTANCES, PROTEUS IS SWARMING WHICH DOES NOT ALLOW FOR GRAM POSITIVE IDENTIFICATION. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2487464 BD BBL COLUMBIA CNA AGAR 500 G CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON DICKINSON & CO. (SPARKS) 4071443 00382902121046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown